Development and preclinical testing of the critical care pain observation tool for family caregiver use (CPOT‐Fam)

Abstract Background and Aims Pain assessment in noncommunicative intensive care unit (ICU) patients is challenging. For these patients, family caregivers (i.e., family members, friends) may be able to assist in pain assessment by identifying individualistic signs of pain due to their intimate patient knowledge. This study adapted the critical care pain observation tool (CPOT) to facilitate pain assessment in adult ICU patients by family caregivers. Methods This study was conducted through three distinct phases: (1) CPOT adaptation for family caregiver use (to create the CPOT‐Fam): A working group met monthly to adapt the CPOT and develop educational material and sample cases for practice scoring until consensus was reached.(2) CPOT‐Fam preclinical testing: Family caregiver study participants viewed educational materials and scored four randomly selected sample cases using the CPOT‐Fam. Scores were compared to reference scores to assess agreement and identify CPOT‐Fam sections requiring revision. Open‐ended feedback on the CPOT‐Fam was collected.(3) CPOT‐Fam revision: the CPOT‐Fam was revised by the working group considering score agreement and feedback received from study participants. Results Of the n = 30 participants, n = 14 (47.0%) had experience with an ICU patient. Agreement between CPOT‐Fam participant scores and reference scores were highest for the vocalization dimension (Is the patient making any sounds?; Intraclass correlation coefficient; ICC = 1.0) and lowest for the body movements dimension (What are the patient's body movements like?; ICC = 0.85. Participants indicated they found the CPOT‐Fam to be “informative” and “easy‐to‐use” but “not graphic enough”; participants also indicated that descriptors like “lack of breath” and “struggling to move” are helpful with identifying individualistic behaviors of pain exhibited by their loved ones. Conclusion The CPOT‐Fam shows ease of use and may be of value in involving family caregivers in ICU care. Clinical pilot testing is needed to determine feasibility and acceptability and identify further areas for refinement.


| INTRODUCTION
Pain is commonly experienced by patients in the intensive care unit (ICU). 1,2 As self-reporting is the gold standard measure of pain, alternative assessment methods are required for patients who are unable to self-report their pain according to their clinical condition and cognitive capacity. 3,4 For these patients, proxy reporters (e.g., parents, children, spouses, professional caregivers) can assist in pain recognition as these individuals are often familiar with the patient's behavior and can pinpoint small changes in patient conduct indicative of pain. 2,4,5 Hospitalized patients' self-reported pain ratings have been reported to be closer in agreement with family caregiver proxy reporters pain ratings rather than ratings by nurses and physicians. 5,6 Therefore, involving family caregivers in pain assessment of patient's unable to self-report may allow for earlier pain recognition, reduce anxiety, and improve satisfaction with care for patients and their loved ones. 7 Of the available pain assessment tools suitable for critically ill patients unable to self-report, the critical care pain observation tool (CPOT) is recommended for clinical use by practice guidelines and widely used. 8,9 The CPOT is comprised of four behavioral items (i.e., categories) to allow assessment of pain in critically ill patients: (1) facial expression; (2) body movements; (3) compliance with ventilator (if intubated) or vocalization (if not intubated); and (4) muscle tension. 10,11 Each item can be scored from 0 to 2 (0 being the lowest score); the scores are additive for a maximum score of 8. 12 The CPOT has shown moderate correlations (0.59 and 0.71; p < 0.05) to selfreported pain intensity during nociceptive procedures in the ICU (such as turning) and reasonable sensitivity (86%) and specificity (78%) when used by ICU clinicians in ventilated and non-ventilated ICU patients. 8,11,13 While the CPOT has been developed for use by clinicians, it has shown suitability for use by proxy reporters of pain (hereon referred to as family caregivers to describe family members and friends). 10 When used by family caregivers given sufficient training, the CPOT has been reported to empower family caregivers to: (1) confirm their observations of pain behaviors, (2) allow more focus on the patient, and (3) advocate for better pain management. 10 However, many family caregivers using the CPOT have not found all dimensions of the tool relevant to their understanding of pain. 10 This may be due to complex terminology describing scoring options in the CPOT, written for use by ICU clinicians.
To address the need for a pain assessment tool suitable for family caregiver use in the ICU, this study aimed to adapt the CPOT for family use and test the tool preclinically to determine its appropriateness and areas for revision.
Specifically, the main objectives for this study were to: (  14 to ensure that individuals with varying educational backgrounds could understand and act upon the information presented. Sample cases was created to reflect each possible scoring combination on the original CPOT (162 unique scoring combinations, 81 for intubated patients, and 81 for non-intubated patients). 12 Clinically unlikely scoring combinations (e.g., an intubated patient who had a score of 0 on facial expression and a score of 2 on compliance with ventilator) were identified through team discussion and excluded, leaving 120 sample cases for use in the preclinical testing phase.

| Study setting, participants, and recruitment
Study participants (including family-caregivers of current or former ICU patients and interested members of the public) were recruited virtually using social media (e.g., Twitter channels) and Bethecure.ca (a resource providing members of the general public information on participating in research and available opportunities), as well as in person at the Foothills Medical Center medical-surgical ICU in Calgary, Canada between October 15 and December 15, 2021. Participants were eligible for inclusion in this study if they were over 18 years of age, able to communicate in English (i.e., understand, read, speak), and able to provide informed consent. To minimize risk of COVID-19 exposure to participants, study materials were provided to participants digitally whenever possible. Consent was obtained verbally (over the telephone) using a recruitment script that ensured potential participants were provided adequate information about the study and understood their role.

| Procedures
Study participants were assigned a unique identification number and provided an online link to view educational materials. Participants were then administered an online, Qualtrics, survey where they were asked to sequentially: (1) assign CPOT-Fam scores to four randomly allocated sample cases, (2) complete a CPOT-Fam follow-up survey, and (3) provide demographic information. The research team facilitated participants' completion of the educational materials, sample cases, the demographic survey, and the follow-up survey by being present to answer questions by telephone or email. All data was stored securely on a University of Calgary-approved digital location in accordance with institutional procedures. Study procedures and instruments used are described in further detail in a peer-reviewed protocol manuscript. 15

| Data analysis
Quantitative data collected from participants was analyzed using Microsoft Excel. Participant characteristics and responses to closedended questions (e.g., multiple choice, yes/no) were compiled into counts and percentages. The intraclass correlation coefficient (ICC) was used to determine agreement and degree of correlation between participant generated CPOT-Fam scores and reference CPOT-Fam scores for all sample cases (ICC determined for each CPOT-Fam question score and total CPOT-Fam score) before being interpreted according to accepted recommendations. 16 The ICC was calculated using Microsoft Excel (version 2207; Microsoft Corporation).
Textual data collected on the follow-up survey (i.e., feedback on the CPOT-Fam) was analyzed using NVIVO 12 (QSR International). A qualitative content analysis was completed by two research team members using an inductive sentiment approach. Research team members independently reviewed the complete data set and identified initial codes that represented categories of feedback received from study participants. The research team members then compared individually identified codes and discussed converging and diverging ideas before finalizing the codebook. All data were coded independently in duplicate using the finalized codebook.

| Sample size and power considerations
Participants were recruited according to an estimate of ICC = 0.85 between participant-assigned CPOT-Fam scores and reference scores (i.e., researcher-assigned scores). To estimate a 95% confidence interval with a width of 0.099 (±0.050), n = 120 sets of scores from n = 30 subjects were required (in which each subject scored 4 sample cases). tension) and scoring system (i.e., 0−2 score on each dimension). 10,11 The lead researcher and patient partners built the CPOT-Fam by first expressing CPOT tool dimensions in question format to increase user-friendliness. For example, the body movements CPOT dimension was posed as the following question in the CPOT-Fam: "What are the patient's body movements like?." Scoring options for each CPOT dimension were also simplified to reflect language that could be understood by individuals without a specific health or educational background. For example, a score of 0 on the body movements dimension is described as "absence of movements or normal position" in the original CPOT. In the CPOT-Fam, this scoring description was modified to "relaxed or comfortable (examples: lying down, sitting, or moving without pain)." The CPOT-Fam was then presented to the sub-working group and two rounds of major revisions and multiple rounds of minor revisions were completed before the group deemed the CPOT-Fam tool ready for preclinical testing.  Table 2). 19

| Participant feedback-closed-ended
All participants who had a personal connection with a current or previous ICU patient (n = 14; 100%) indicted that they would feel empowered to act if they identified pain in their family member. Of these, 10 (71.0%) participants indicated they felt extremely comfortable or somewhat comfortable in their ability to tell whether a loved one was experiencing pain, whereas 4 (28.6%) participants indicated they felt extremely or somewhat uncomfortable in doing this.

| Revision of the CPOT-Fam
The working group was assembled once again in January 2022 to discuss actionable feedback received from participants during the    2,20 suggesting that certain family caregivers may be more suited to accurate proxy pain assessment than others. While these studies were conducted with patients who were able to self-report their pain, so comparisons with their family caregivers' pain assessment could be made, it is reasonable to imagine that family caregivers' familiarity with a patient's individualistic pain behaviors could contribute to clinicians' pain assessment for noncommunicative patients.
While family caregivers could be well-equipped to assist in pain assessment of ICU patients, others could benefit from structure (e.g., a tool) to assist them in this endeavor. In a study of the relevance of pain behaviors in traumatic brain injury patients in ICU, family caregivers rated facial expressions such as tearing or brow lowering and body movements such 22 as attempting to touch the pain site to be most representative of the patients' pain. 5 However, while family caregivers were able to pinpoint specific behaviors of pain in a patient, two studies have found that family caregivers tend to slightly overestimate pain in their loved ones (16.8% of the time in one study), 20 particularly in ventilated patients. 21 This could be due to anxiety and distress arising from witnessing pain in a loved one. 22 Information around the emotional effect of assessing pain on family caregivers is limited and was not collected in our current study. The provision of a structure that family caregivers can use to identify pain in their noncommunicative loved one may be able to help family caregivers assess pain in a critically ill patient more objectively. As pain behaviors described by family caregivers in this study relate to the facial expressions and body movements dimensions in original CPOT, the tool stands a good chance of adaptability for family use.

| Conclusions
In this study, the CPOT-Fam was developed to provide family caregivers with a structured tool to use in pain assessment of an adult SHAHID ET AL. Thomas Stelfox. The funding source had no involvement in study design, collection, analysis and interpretation of data, writing of the report, or the decision to submit the report for publication.

CONFLICT OF INTEREST
The authors declare no conflict of interest.

DATA AVAILABILITY STATEMENT
The data that support the findings of this study are available from the corresponding author upon reasonable request. Dr. Henry Thomas Stelfox had full access to all of the data in this study and takes complete responsibility for the integrity of the data and the accuracy of the data analysis.

TRANSPARENCY STATEMENT
The lead author Dr. Henry T. Stelfox affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.